The use of implantable prosthesis for human body recontouring, for use primarily in the area of breast reconstruction following traumatic or surgical loss of breast tissue or, electively to augment a condition of developmental hypoplasia has been documented for over 80 years. Typically, the prosthesis or implant consists of a flexible envelope containing a liquid or gelatinous material. The envelope is commonly made from silicone, polyurethane or other bio-compatible polymers with varying degrees of elastic memory and permeability. Prior art implants have been filled with a variety of materials such as foam rubber, saline and silicone oil or gel.
For many years, silicone filled implants were held out as the clinically accepted standard and superior to other known filling agents, silicone being an inert substance and a natural lubricant. However, silicone filled implants have come under recent criticism by governmental regulatory agencies, members of the medical community and the public at large due to widespread reports of chronic adverse effects such as inflammation, calcification, allergic reactions and even more serious complications resulting from either traumatic rupture of the envelope or the migration of silicone through the envelope membrane or valve into the surrounding tissue and even into the bloodstream. The human body is incapable of eliminating the silicone, thereby requiring the surgical removal of the silicone and treatment of the resulting complications or disease states. Another disadvantage of silicone filled implants is that silicone is radiopaque or radiodense, causing significant obstruction and interference with radiology procedures.
Saline filled implants have for some time been considered a viable alternative to silicone implants and have recently, by default, become the implant/fillant of choice. Implants filled with physiological saline (0.9%) are isotonic and bio-compatible with the fluids of the human body. Therefore, the human body possesses the ability to eliminate the saline which may leak from the implant. In the case of traumatic rupture of the implant, the liberated contents would be essentially non-toxic and non-life threatening to the patient. Saline implants also have the advantage of being radiolucent, but are less desirable than silicone because of saline's low viscosity. Additionally, saline is inherently a poor lubricant and as a result, envelopes of saline filled implants appear to rupture more quickly because of the friction caused when an envelope rubs against itself.
Procedures describing the use of free fat in breast augmentation have also been documented. In these procedures, autologous fat, obtained through liposuction, is aseptically collected and, thereafter, drawn into a syringe for subsequent transcutaneous injection. The fat is injected into multiple areas of the breast in small quantities. However, these procedures appear controversial. Incidences of fat necrosis producing localized inflammation and tumor-like masses, as well as the production of calcifications or nodules formed from the complexing of fatty acids with calcium in tissue fluid have been recorded.
In light of the deficiencies in the prior art, applicant's invention is herein disclosed. Drawings have been provided to illustrate, method for extracting and collecting the fat tissue and subsequently introducing a predetermined volume of fat into a flexible envelope.